4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with the drug that
emerged during Food and Drug Administration testing, a former FDA scientist
tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of people who took
the drug have sued American Home Products of Madison, N.J., for health
problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent Sharyl Attkisson
reports the FDA’s key reviewer of fen-phen, Dr. Leo Lutwak, claims the
company knew about the problems long before the drug was pulled.

“I felt from the very beginning the drug companies were covering up. I felt
from the very beginning that these drugs were dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his research to make
it seem as if there was no way to predict fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of predicting some of
these side effects,” he said.

One of those who sued American Home Products was Patricia Buol, who developed
severe heart problems after taking fen-phen. She’s now in line for a life
saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is a
struggle,” said Buol. “But I just take one day at a time and do the best I
can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s. But the FDA
won’t let him testify. Now Lutwak says he’s planning to retire, making him
free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to work
within the system, it didn’t work. People died as a result of a dangerous
deadly drug being released,”he said.

Defendant American Home Products would not be interviewed, but has said in
the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request to answer the
allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the agency’s
current approach to drug regulation.

“I have some concerns that we may be losing sight of what the FDA is all
about,” said Kessler. “The question is, who’s the agency’s customers? Who’s
the agency partner?”

Consumer advocates say the FDA is constantly keeping damaging information
from the public.

“They view the drug industry in many ways as their customers, at least the
bosses do, as opposed to viewing the public as the customers they need to
protect from some of the excesses of the drug industry,” said Sidney Wolfe of
Public Citizen.

Concerns about the FDA also emerged during the controversy over the diabetes
drug Rezulin.

Kessler said the agency needs to realize the American consumer is its
customer.

American Home Products also makes such drugs as Caordarone, Sectral,
Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine and
phentermine, which work by suppressing the appetite of a person who is trying
to lose weight.

It was estimated that in 1996, 18 million Americans took the drugs.

But a report in the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary hypertension, a rare, almost
always fatal, disease. It was also linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new evidence about
significant side-effects,” asked the manufacturers to voluntarily withdraw
both medications, marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, complied.

However, the company continued to deny the drugs caused the alleged problems.
In November, 1998, Wyeth-Ayerst published a study that compared heart
function in people who had taken fen-phen and a group who hadn’t, and
concluded there was “no significant differences in cardiovascular clinical
outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News & World Report
revealed that Wyeth-Ayerst knew more than it told about the pulmonary
hypertension risks, a charge the company denied.

In September 1999, the Wall Street Journal reported that the FBI was
investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to $4.83 billion to
settle the more than 11,000 fen-phen lawsuits, one of the biggest product
liability settlements ever.

As part of the settlement agreement, the company admitted no wrongdoing.

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My Trip through Hell on Prozac

“By my 9th week on Prozac I felt suicidal.”

 

My name is Amy. I started taking 20 mg. of Prozac in April, 1992. My doctor thought I was depressed due to “empty nest syndrome” and menopause. I had always been a very open and trusting person, so I swallowed my first capsule without reading the insert in the bottle. I trusted my doctor.

The first week I noticed I was sleeping less. I had been sleeping between 7 and 8 hours a night and now I was sleeping about 6 hours a night. But this did not concern me. I suddenly had a lot to ponder. I began ruminating on how “people had done me wrong.”. I first focused on my 3 cousins (whom I had not seen in years). I thought they were betraying me behind my back. To add to this worry, I began obsessing about incidents in history such as the destruction of Cambodia and Tibet by the Communists and the tragedy of the Holocaust. I sat at my kitchen table and cried for hours about this.

At my part time job, I felt that the other employees were taking advantage of me. I had never felt this way before and it seemed like a revelation to me. By the 4th week on Prozac, I was sleeping only 4 hours a night but it did not concern me because I had so many important things to think about.

I would pick up a book to read and would think that there was some special message in there for me. I was sure of this when the printed matter on the page began jumping out at me. Nothing like this had ever happened to me before. I began to make a special effort to act normal around people because suddenly these people would appear to me as being unreal. I became terrified that they were unreal but I must not let them know this.

During the next several weeks I became confused in my driving and would lose my sense of direction. I thought that I could not concentrate on my driving because I was so terrified of what else was happening. I never once suspected that it was the Prozac.

My husband of 28 years became concerned about me but I kept saying “I’ll be better as soon as this Prozac takes effect”. I told him none of my symptoms. I felt that everything wrong in the world was my problem and I must solve it.

At no time in my life had I ever thought of suicide. It wasn’t as though I had ever thought of suicide and then dismissed the idea. It was just that the thought of suicide had never occurred to me. By my 9th week on Prozac I felt suicidal. I went to my doctor and told him that I was going to kill myself because I could not endure this suffering. He immediately told me to discontinue the Prozac and he gave me some sleeping medication. I thought this meant that the Prozac had not worked for me and that I was having a nervous breakdown.

The next day I began having visual hallucinations. I was so terrified that I went to my doctor in an incoherent state. He put me in the hospital and I was there for 3 weeks as an inpatient. My husband visited me every night after work. We both thought that I had a nervous breakdown. No doctor told us differently. I was given Thorazine and I began to sleep again. Then my health insurance ran out and I came back home.
When I left the hospital, I was told to see a psychologist once a week. The psychologist and I discussed my childhood.

One day, three months later, my husband said ” Do you think the Prozac could have contributed to your breakdown”. “No”, I said, “Prozac is a drug that helps mental disturbances. It would not cause mental disturbance.

“My husband found the insert to my bottle of Prozac. We began to read it. We saw that hallucinations, depersonalization, paranoia and confusion were all listed as adverse reactions. I still could not believe it so I sent for my hospital record.

I was amazed to see that on the fourth day of my hospitalization the physician had written “Patient had psychotic reaction to Prozac. These symptoms started after use” We investigated this matter but were never given a satisfactory answer for why the doctors kept this a secret.
The saddest part of this story is that it took so long for me to completely recover. It was close to 2 years before I could laugh again. It was almost 4 years before the idea of forgiveness even began to stir in my soul.
Now, in my 6th year, I am completely recovered and enjoying life again, but I will never forget this trip through hell. My husband, children and I are now dedicated to warning others about the dangers of Prozac.

Amy Lend
amylend@yahoo.com

 

5/20/1998 –

Years 2000 and Prior

This is Survivor Story number 35.
Total number of stories in current database is 96

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